Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-27 @ 8:47 PM
Study NCT ID:
NCT07015450
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Self-Manufactured 40% Dextrose Gel in Asymptomatic Transient Neonatal Hypoglycemia Treatment
Sponsor:
Indonesia University
Organization:
Study Overview
Official Title:
The Efficacy of Self-Manufactured 40% Dextrose Gel as Supplementary to Asymptomatic Transient Neonatal Hypoglycemia Treatment : A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine the efficacy of 40% dextrose gel therapy as an additional therapy for the management of asymptomatic transient neonatal hypoglycemia in high risk infants
The main question it aims to answer is:
Is 40% dextrose gel effective for the management of asymptomatic transient NH in high risk infants?
Researchers will compare the use of 40% dextrose gel as an additional therapy to the standard treatment and the use of breastmilk or formula milk according standard hypoglycemia treatment only to see if 40% dextrose gel is superior than standard therapy for management as asymptomatic transient NH in high risk infants.
Participants will :
* Receive 40% dextrose gel plus standard therapy or standard therapy only
* Blood glucose level measurement (30 minutes after intervention)
The main question it aims to answer is:
Is 40% dextrose gel effective for the management of asymptomatic transient NH in high risk infants?
Researchers will compare the use of 40% dextrose gel as an additional therapy to the standard treatment and the use of breastmilk or formula milk according standard hypoglycemia treatment only to see if 40% dextrose gel is superior than standard therapy for management as asymptomatic transient NH in high risk infants.
Participants will :
* Receive 40% dextrose gel plus standard therapy or standard therapy only
* Blood glucose level measurement (30 minutes after intervention)
Detailed Description:
Background: Neonatal hypoglycemia (NH) is a metabolic disorder that often occurs in the first few days of life. It is a potential cause of preventable brain injury and neonatal death. Most of hypoglycemia in high risk infants are transient and asymptomatic. One of the additional therapy for asymptomatic transient neonatal hypoglycemia is 40% dextrose gel. The 40% dextrose gel is a promising therapy because it is inexpensive, easy to administer and non-invasive.
Objective: To determine the efficacy of 40% dextrose gel therapy as an additional therapy for the management of asymptomatic transient NH in high risk infants.
Methods: A single-blind, randomized controlled trial was carried out in April-August 2023. The inclusion criteria were infants \>34 weeks of gestational age and birth weight \>1500 grams with blood sugar levels of 27-\<47 mg/dL and without hypoglycemic symptoms. Block randomization was carried out in 60 eligible subjects. Subjects were allocated to 2 groups, the treatment group (40% dextrose gel plus standard therapy) and control group (standard therapy). The self-manufactured 40% dextrose gel was applied in buccal mucosa region. Blood glucose level was measured with glucometer 30 minutes after intervention. Data presented in descriptive and analyzed using chi-square and independent t-test with p\<0.05.
Objective: To determine the efficacy of 40% dextrose gel therapy as an additional therapy for the management of asymptomatic transient NH in high risk infants.
Methods: A single-blind, randomized controlled trial was carried out in April-August 2023. The inclusion criteria were infants \>34 weeks of gestational age and birth weight \>1500 grams with blood sugar levels of 27-\<47 mg/dL and without hypoglycemic symptoms. Block randomization was carried out in 60 eligible subjects. Subjects were allocated to 2 groups, the treatment group (40% dextrose gel plus standard therapy) and control group (standard therapy). The self-manufactured 40% dextrose gel was applied in buccal mucosa region. Blood glucose level was measured with glucometer 30 minutes after intervention. Data presented in descriptive and analyzed using chi-square and independent t-test with p\<0.05.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: